Skin Cancer Prevention Strategies for Skin Cancer

(RISE-UP Trial)

Overseen By Yelena Wu, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Utah

Disqualifiers: Non-English speakers, Skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

528 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best ways to prevent sunburns and promote sun protection. It will test various strategies, such as personalized action plans (the "Action Plan"), genetic testing for skin cancer risk (the "MC1R Test"), and educational tools ("Education"), both individually and in combination. The goal is to determine which approach or combination is most effective over a year. Ideal participants are undergraduate students who have experienced a sunburn or tanned at least once in the past year. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking sun protection strategy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this study are generally safe for participants.

For the Education component, studies have found that teaching about skin cancer and sun safety is well-received, with no reported side effects. Education helps individuals learn and practice sun protection.

The Action Plan involves creating personalized sun safety strategies based on safe and recommended guidelines, such as those from the U.S. Environmental Protection Agency, for preventing skin cancer.

The UV Photo treatment uses special photography to reveal sun damage on the skin. Studies show this method raises awareness about sun safety without causing harm. Participants often find it eye-opening and helpful for understanding the effects of UV exposure.

The MC1R Test is a genetic test to assess individual skin cancer risk. Although some may feel anxious about genetic testing, studies have not reported any serious negative outcomes from the test itself. It is a simple saliva test.

Overall, these components aim to inform and promote sun-safe behavior without health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these skin cancer prevention strategies because they incorporate personalized and engaging techniques that go beyond traditional education. Unlike standard sun safety recommendations, some approaches in this trial use MC1R genetic testing to tailor advice based on individual genetic risk for skin cancer. Additionally, the use of UV photos provides a visual representation of sun damage, making the dangers of UV exposure more tangible and encouraging proactive behavior. These innovative strategies aim to enhance awareness and motivation for sun protection, potentially offering more effective prevention than the current one-size-fits-all advice.

What evidence suggests that this trial's treatments could be effective for skin cancer prevention?

This trial will evaluate various strategies for skin cancer prevention. Research has shown that educational programs, which participants in this trial will receive, can help people change their sun protection habits and reduce sun exposure, aiding in skin cancer prevention. These programs provide important information about the risks and effects of skin cancer, leading to greater awareness and better sun safety practices.

Participants in different arms of this trial may also receive a personalized Action Plan. Studies indicate that setting specific goals, such as wearing sunscreen or staying in the shade, can improve sun protection habits.

Some participants will undergo the MC1R test, which provides genetic information that can increase awareness of personal skin cancer risk and potentially lead to better sun protection habits.

Additionally, certain trial arms will include UV Photography. This method can strongly influence sun protection habits by visually demonstrating the effects of sun exposure, encouraging better sun safety practices. Together, these strategies aim to prevent sunburn and lower the risk of skin cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Jennifer Hay, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Yelena Wu, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for undergraduate students over 18 who have tanned indoors once in the past year, experienced at least one sunburn last year, and use sunscreen or other sun protection infrequently. They must also engage in outdoor tanning to some degree. Those with a history of skin cancer or who don't read/speak English cannot participate.

Inclusion Criteria

You have used indoor tanning at least once in the past year.

I had at least one sunburn in the past year.

Enrolled as an undergraduate student

Exclusion Criteria

I have had skin cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment on sunburn occurrence, sun protection behaviors, and tanning behaviors

1 week

1 visit (virtual)

Intervention

Participants receive the optimized intervention including education on skin cancer and prevention strategies, and may receive UV Photo, Action Plan, and/or MC1R Testing

1 month

1 visit (in-person)

Post-Intervention Assessment

Participants complete assessments at 1-month, 4-months, and 15-months post-intervention to evaluate sunburn occurrence and sun protection behaviors

15 months

3 visits (virtual)

Follow-up

Participants are monitored for changes in sunburn occurrence, sun protection behaviors, and tanning behaviors

15 months

What Are the Treatments Tested in This Trial?

Interventions

• Action Plan
• Education
• MC1R Test
• UV Photo

Trial Overview The study tests whether UV photos, an action plan for sun protection, and MC1R genetic testing can prevent sunburns among undergraduates. Participants will be assessed four times over 15 months to see which methods work best alone or combined.

How Is the Trial Designed?

Group I: Education + UV Photo + MC1R Test Experimental Treatment 3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group II: Education + UV Photo Experimental Treatment 2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.

Group III: Education + MC1R Test Experimental Treatment 2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group IV: Education + Action Plan + UV Photo + MC1R Test Experimental Treatment 4 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group V: Education + Action Plan + UV Photo Experimental Treatment 3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.

Group VI: Education + Action Plan + MC1R Test Experimental Treatment 3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group VII: Education + Action Plan Experimental Treatment 2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure.

Group VIII: Education Experimental Treatment 1 Intervention

Students in this intervention will receive education on skin cancer and prevention strategies.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Skin cancer is highly preventable, especially in sun-sensitive populations, and effective primary prevention campaigns are crucial for raising awareness about sun protection measures.

Current prevention initiatives have had limited success in changing behaviors or reducing skin cancer mortality, particularly among elderly men, who are the most affected demographic for melanoma mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population education in preventing skin cancer: from childhood to adulthood. de Haas, ER., Nijsten, T., de Vries, E.[2010]

In a 3-month trial involving 1000 at-risk women, those who received online education on skin self-examination (SSE) showed a significantly higher initiation rate of SSE (96.2%) compared to the control group (48.1%), indicating the effectiveness of educational interventions in promoting self-monitoring for melanoma.

Women in the SSE group not only increased their confidence in performing skin checks but also identified more atypical nevi (38.5% vs. 8.4%) and melanomas (25.6% vs. 4.7%) during healthcare visits, suggesting that SSE education can enhance early detection of skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanoma detection by skin self-examination targeting at-risk women: A randomized controlled trial with telemedicine support for concerning moles. Robinson, JK., Wahood, S., Ly, S., et al.[2023]

The educational intervention was well-received by both parents and children, leading to a significant increase in knowledge about melanoma risk and preventive behaviors among participants.

After the intervention, children reported a higher perceived risk of melanoma and showed increased engagement in sun protective behaviors, indicating the intervention's effectiveness in promoting preventive actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel educational intervention targeting melanoma risk and prevention knowledge among children with a familial risk for melanoma. Wu, YP., Nagelhout, E., Aspinwall, LG., et al.[2019]

The Task Force on Community Preventive Services recommends two effective interventions to reduce unprotected UV exposure and skin cancer risk: educational and policy approaches in primary schools and recreational sites that promote sun protective behaviors like wearing protective clothing.

There is insufficient evidence for the effectiveness of various other interventions, highlighting the need for further research in areas such as child care centers, secondary schools, and community-wide campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing skin cancer: findings of the Task Force on Community Preventive Services On reducing Exposure to Ultraviolet Light. Saraiya, M., Glanz, K., Briss, P., et al.[2016]

A study involving 39 melanoma survivors showed that 84.6% found UVR sensors useful for understanding sun exposure conditions and receiving real-time alerts, indicating a strong interest in using technology to enhance sun protection.

Participants expressed a desire for UVR sensors to be small and integrated with other devices, but also raised concerns about the interpretability and convenience of wearing such sensors in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward a precision behavioral medicine approach to addressing high-risk sun exposure: a qualitative analysis. Stump, TK., Spring, B., Marchese, SH., et al.[2022]

Education during well-child examinations is crucial for melanoma prevention, as it allows healthcare providers to inform patients and parents about risk factors and preventive measures.

The primary modifiable risk factor for melanoma is sun exposure, and patients should be advised on sun avoidance, protective clothing, and proper sunscreen application to reduce their risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nevi in children: a practical approach to evaluation. Prok, LD., Arbuckle, HA.[2019]

Inherited variations in the MC1R gene are a strong indicator of increased melanoma risk, even in individuals who may not show typical signs of sun sensitivity.

Research into MC1R genetic risk screening could lead to better prevention and early detection of melanoma, potentially improving outcomes through early surgical intervention or reducing the overall incidence of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marshaling the Translational Potential of MC1R for Precision Risk Assessment of Melanoma. Kanetsky, PA., Hay, JL.[2023]

A study involving 50 patients with a history of nonmelanoma skin cancer showed high interest in genetic testing for melanoma risk, with 92% of those who logged onto the study website opting for testing and 95% returning their saliva samples.

After receiving risk feedback from MC1R testing, most participants reported low distress levels and significant communication about skin cancer risk with family (92%) and physicians (80%) by three months, indicating that genetic testing can facilitate important health discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest and Utility of MC1R Testing for Melanoma Risk in Dermatology Patients with a History of Nonmelanoma Skin Cancer. Hay, JL., Lee, EH., Christian, SN., et al.[2022]

A study involving 1,573 high school students tested four different interventions to improve skin cancer prevention behaviors, all of which significantly increased sun protection practices.

The intervention using a personalized UV damage photograph was most effective in reducing intentional tanning and sunburn, while a behavior change worksheet was better at increasing overall sun protection use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A four-group experiment to improve Western high school students' sun protection behaviors. Wu, YP., Parsons, BG., Nagelhout, E., et al.[2020]

A new patient counseling approach for sun protection was developed specifically for outdoor workers diagnosed with skin conditions related to UV exposure, based on qualitative interviews and expert reviews.

The counseling program includes customizable modules that address individual patient needs, emphasizing interactive and educational components to improve sun protection behaviors among outdoor workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary prevention of UV-induced skin cancer: development and pilot testing of an educational patient counseling approach for individual sun protection as standard procedure of patient care. Ludewig, M., Rocholl, M., John, SM., et al.[2022]

A new educational intervention has been developed for children aged 8-17 with a family history of melanoma, focusing on understanding their risk and preventive behaviors like sun protection.

The intervention combines insights from various fields, including dermatology and health education, to effectively communicate the importance of preventing DNA damage and reducing melanoma risk in at-risk children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Educational Program Integrating Concepts of Genetic Risk and Preventive Strategies for Children with a Family History of Melanoma. Wu, YP., Aspinwall, LG., Nagelhout, E., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3815976/

Randomized Trial of Tailored Skin Cancer Prevention for ... Sun protection habit scores averaged 2.19, between “sometimes” and “usually” on the 4 point scale. Over 90% of the responding parents were mothers, almost 90% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9931317/

Effectiveness of a tailored web app on sun protection ... SUNsitive was developed to provide a stand-alone, individually tailored feedback on skin cancer prevention through UV-light protection (sun, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003112

The Risk Information and Skin-cancer Education for ... The primary outcome will be participants' self-reported number of sunburns. Secondary outcomes will include self-reported sun protection and tanning behaviors ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743508001126

The formation of specific action plans can enhance sun ... This is the first study to report on the efficacy of implementation intentions in the area of sun protection behavior and skin cancer prevention. The results ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/48/NCT03028948/Prot_SAP_001.pdf

CINJ Protocol Template These studies demonstrate the need to develop and disseminate effective interventions to promote skin surveillance and sun protection behaviors among melanoma ...

6. cdc.gov cdc.gov/skin-cancer/sun-safety/index.html

Sun Safety Facts | Skin Cancer Most skin cancers are caused by too much exposure to ultraviolet (UV) light. Protection from UV rays is important all year.

7. epa.gov epa.gov/sunsafety/sun-safety-tips

Sun Safety Tips | US EPA Avoid Sun Tanning and Tanning Beds. UV radiation from tanning beds and the sun causes skin cancer and wrinkling. Generously Apply Sunscreen.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK247176/

The Surgeon General's Call to Action to Prevent Skin Cancer Develop an action plan to promote campuswide UV protection strategies. Strategy 4D. Enforce existing indoor tanning laws and consider adopting additional ...

9. cancercouncil.com.au cancercouncil.com.au/wp-content/uploads/2022/03/CCNSW-Outdoor-Worker-Action-Plan.pdf

When your workers are outside, you want sun protection to ... Officially launch your Sun Safety Action Plan. Clearly communicate what changes will occur and what you expect from all staff. Use posters, newsletters, your ...

10. epa.gov epa.gov/sunsafety/action-steps-sun-protection-0

Action Steps for Sun Protection June 2010 fact sheet explaining simple steps to protect yourself and your children from overexposure to ultraviolet radiation.